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510(k) K191396

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe by HORIBA ABX SAS — Product Code CJY

K191396 is an FDA 510(k) premarket notification submitted by HORIBA ABX SAS for the device "Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe". The FDA issued a decision of Substantially Equivalent on July 26, 2019. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. HORIBA ABX SAS has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2019
Date Received
May 24, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo Dye, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by HORIBA ABX SAS

  • K232946 — Yumizen H2500 (May 21, 2024)
  • K193649 — Yumizen C1200 Creatinine PAP (May 10, 2021)
  • K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Im (June 26, 2020)
  • K192028 — Yumizen C1200 CRP (June 25, 2020)
  • K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Fact (March 6, 2020)
  • K191993 — Yumizen C1200 CRP (October 3, 2019)
  • K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin (August 30, 2019)
  • K170353 — ABX MICROS ES 60 OT and ABX MICROS ES 60 CT (November 1, 2017)
  • K151133 — PENTRA XLR (December 9, 2015)
  • K141161 — ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) (December 20, 2014)

Other clearances for product code CJY

  • K244042 — Calcium2 (February 10, 2025)
  • K182042 — Randox Calcium (Ca) (October 23, 2018)
  • K151113 — ELITech Clinical Systems CALCIUM ARSENAZO (July 22, 2015)
  • K123171 — ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX (July 3, 2013)
  • K120626 — EON CALCIUM REGENT (August 22, 2012)
  • K083386 — ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 0 (April 2, 2009)
  • K072356 — S-TEST CA (June 24, 2008)
  • K073355 — CALCIUM, SCAL, NORTROL, ABTROL (February 28, 2008)
  • K072443 — VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (September 24, 2007)
  • K072440 — VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL (September 20, 2007)

FDA data resources